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Trial registered on ANZCTR


Registration number
ACTRN12612000494831
Ethics application status
Approved
Date submitted
3/05/2012
Date registered
7/05/2012
Date last updated
9/05/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Altered Circadian Rhythm of Melatonin Secretion and Circadian Gene Expression in the Early Stage of Sepsis
Scientific title
In sepsis patients, do melatonin secretion and circadian gene expression compared to non-septic patients alter from their normal rhythm?
Secondary ID [1] 280432 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sepsis 286405 0
Condition category
Condition code
Inflammatory and Immune System 286655 286655 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Eleven septic patients critical illness patients were enrolled in this prospective study. Peripheral blood was drawn every four hours from 2 p.m. on their first ICU day up to 24 hrs. Plasma levels of melatonin, tumor necrosis factor (TNF)-a and interleukin (IL)-6 were measured by radioimmunoassay or enzyme-linked immunosorbent assay. Message RNA levels of circadian genes, Cry-1 and Per-2, were analyzed using quantitative real-time polymerase chain reaction.
Intervention code [1] 284791 0
Not applicable
Comparator / control treatment
Eleven non-septic critical illness patients were enrolled in this prospective study. Peripheral blood was drawn every four hours from 2 p.m. on their first ICU day up to 24 hrs. Plasma levels of melatonin, tumor necrosis factor (TNF)-a and interleukin (IL)-6 were measured by radioimmunoassay or enzyme-linked immunosorbent assay. Message RNA levels of circadian genes, Cry-1 and Per-2, were analyzed using quantitative real-time polymerase chain reaction.
Control group
Active

Outcomes
Primary outcome [1] 287057 0
Plasma levels of melatonin measured by radioimmunoassay kit
Timepoint [1] 287057 0
Every 4 hours from 2 p.m. on their first ICU day up to 24 hrs
Primary outcome [2] 287058 0
Message RNA levels of circadian genes, Cry-1 and Per-2, analyzed using quantitative real-time polymerase chain reaction.
Timepoint [2] 287058 0
Every 4 hours from 2 p.m. on their first ICU day up to 24 hrs
Secondary outcome [1] 297280 0
TNF-a and IL-6 measured by radioimmunoassay or enzyme-linked immunosorbent assay.
Timepoint [1] 297280 0
Every 4 hours from 2 p.m. on their first ICU day up to 24 hrs

Eligibility
Key inclusion criteria
critically ill patients (both sepsis and non-sepsis patients) admitted to the studied ICU in a university hospital
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with insomnia or mental illness; 2. Patients who had shift work before admission to the hospital; 3. Patients who received ß-blockers, melatonin or blocking agents of melatonin.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4285 0
China
State/province [1] 4285 0

Funding & Sponsors
Funding source category [1] 285191 0
Self funded/Unfunded
Name [1] 285191 0
none
Address [1] 285191 0
none
Country [1] 285191 0
Primary sponsor type
Hospital
Name
the First Affiliated Hospital of Wenzhou Medical College
Address
2 Fuxuexiang, Wenzhou, China 325000
Country
China
Secondary sponsor category [1] 284059 0
None
Name [1] 284059 0
none
Address [1] 284059 0
none
Country [1] 284059 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287197 0
Ethical Committee of the First Affiliated Hospital of Wenzhou Medical College
Ethics committee address [1] 287197 0
2 Fuxuexiang, Wenzhou, China 325000
Ethics committee country [1] 287197 0
China
Date submitted for ethics approval [1] 287197 0
Approval date [1] 287197 0
Ethics approval number [1] 287197 0

Summary
Brief summary
This study will investigate the melatonin secretion and its rhythm in septic patients in ICU compared to that in non-septic patients, as well as circadian gene expression and TNF-a and IL-6 level.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34133 0
Address 34133 0
Country 34133 0
Phone 34133 0
Fax 34133 0
Email 34133 0
Contact person for public queries
Name 17380 0
Xiangming Fang
Address 17380 0
Department of Anethesiology, the First Affiliated Hospital of Zhejiang Univeristy. 79 Qingchun Road, Hangzhou, China 310003
Country 17380 0
China
Phone 17380 0
+86 13857161019
Fax 17380 0
Email 17380 0
xiangming_fang@163.com
Contact person for scientific queries
Name 8308 0
Xiangming Fang
Address 8308 0
Department of Anethesiology, the First Affiliated Hospital of Zhejiang Univeristy. 79 Qingchun Road, Hangzhou, China 310003
Country 8308 0
China
Phone 8308 0
+86 13857161019
Fax 8308 0
Email 8308 0
xiangming_fang@163.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary